Tissue expander improvements

ABSTRACT

Improvements for use with tissue expanders are provided. A first aspect includes a tissue expander device provided with a colorant inside a shell before the shell is inflated with fluid, wherein the colorant mixes with fluid upon injection of fluid into the shell. A second aspect includes a tissue expander device provided with a tread on an exterior surface of the shell. A third aspect includes a system having: a computing device with a visual display screen; a detector connected to the computing device that is configured to detect a port of a tissue expander that is implanted under skin of a patient; and software running on the computing device that receives signals from the detector and causes the visual display screen to show a visual representation of a location of the detected port of the tissue expander.

CROSS REFERENCE

This application claims priority to U.S. Provisional Patent ApplicationNo. 61/892,847, filed Oct. 18, 2013, the contents of which areincorporated by reference in their entirety.

FIELD OF THE INVENTION

The invention generally relates to medical devices and associatedmethods of manufacture and use, and more particularly to tissueexpanders.

BACKGROUND

Breast reconstruction with a tissue expander (TE) is currently the mostcommon technique used for breast reconstruction. Typically immediatelyafter the female has a mastectomy the reconstructive medicalprofessional places a tissue expander which serves to stretch the skinand muscle in order to make room for a future implant or maintain theexisting skin envelope. Prosthetic reconstruction of the breast, as astaged procedure with tissue expanders followed by implants, is areliable method for breast reconstruction that offers favorableaesthetic and psychological results while adding only minimal additionalsurgical intervention. Today, the process usually involves the placementof a tissue expander under the pectoralis major muscle and remainingskin of the absent breast. The tissue expander is then graduallyinflated over several weeks or months by periodic injections of saline,causing the stretching and expansion of the overlying skin and musclecoverage. When adequate coverage is achieved, the tissue expander istypically removed, and a permanent breast implant is placed into theexpanded space.

SUMMARY

In a first aspect of the invention, there is a tissue expander devicecomprising: a selectively inflatable and deflatable shell that isconfigured to be implanted; at least one port for selectively inflatingand deflating the shell; and a colorant inside the shell before theshell is inflated with fluid, wherein the colorant mixes with the fluidupon injection of fluid into the shell. In embodiments, the colorant isdehydrated and the injecting the fluid into the shell to inflate thebody rehydrates the colorant. In embodiments, upon mixing with theinjection fluid, the colorant turns the clear injection fluid to anothernon-clear color. In embodiments, a wafer or sticker or tab of thecolorant is placed on an underside of the at least one port, or on aninside surface of the interior wall of the shell. In embodiments, thecolorant is biocompatible. Aspects of the invention also include amethod of manufacturing the tissue expander device. Aspects of theinvention also include a method of using the tissue expander device.

In another aspect of the invention, there is a tissue expander devicecomprising: a selectively inflatable and deflatable shell that isconfigured to be implanted; at least one port for selectively inflatingand deflating the shell; a tread on an exterior surface of the shell. Inembodiments, the tread is on a back side of the shell. In embodiments,the tread comprises a first area and a second area, the first area has aplurality of treads in a first direction, and the second area has aplurality of treads in a second direction different than the firstdirection. In embodiments, the tread comprises a third area and a fourtharea, the third area has a plurality of treads in a third direction, thefourth area has a plurality of treads in a fourth direction, and thefirst, second, third, and fourth directions are all different from oneanother. In embodiments, the tread is one of adhesively attached to theshell, welded to the shell, and molded with the shell. In embodiments,the tread covers the entire back surface of the shell. In otherembodiments, the tread covers discrete spots on the back surface of theshell. Aspects of the invention also include a method of manufacturingthe tissue expander device. Aspects of the invention also include amethod of using the tissue expander device.

In another aspect of the invention, there is a tissue expander devicecomprising: a selectively inflatable and deflatable shell that isconfigured to be implanted; at least one port for selectively inflatingand deflating the shell; a tread on an exterior surface of the shell;and a colorant inside the shell before the shell is inflated with fluid,wherein the colorant mixes with the fluid upon injection of fluid intothe shell. Aspects of the invention also include a method ofmanufacturing the tissue expander device. Aspects of the invention alsoinclude a method of using the tissue expander device.

In another aspect of the invention, there is a system comprising: acomputing device with a visual display screen; a detector connected tothe computing device that is configured to detect a port of a tissueexpander that is implanted under skin of a patient; and software runningon the computing device that receives signals from the detector andcauses the visual display screen to show a visual representation of alocation of the detected port of the tissue expander. In embodiments,the detector and software are configured to change the display based onchanging at least one of the location and orientation of the detectorrelative to the port. In embodiments, the detector and software areconfigured to change the display based on at least one of translating,rolling, pitching, and yawing the detector relative to the port. Inembodiments, the detector and software are configured to change thedisplay to show visual indicator when the detector is located andoriented in a correct position relative to the port. In embodiments, thecomputing device is a smartphone and the software is an app running onthe smartphone.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The present invention is described in the detailed description whichfollows, in reference to the noted plurality of drawings by way ofnon-limiting examples of exemplary embodiments of the present invention.

FIG. 1 shows a system used for tissue expansion, which may include atissue expander, a magnet, and a fluid delivery system.

FIG. 2 shows an example of a fluid delivery system providing access toan access port of a tissue expander.

FIG. 3 provides an example of a tissue expander.

FIG. 4 shows an additional view of a tissue expander with integratedports.

FIGS. 5 and 6 show aspects of a tissue expander with colorant inaccordance with aspects of the invention.

FIGS. 7-11 show aspects of a tissue expander tread in accordance withaspects of the invention.

FIGS. 12-14 show aspects of a tissue expander locator in accordance withaspects of the invention.

DETAILED DESCRIPTION

The particulars shown herein are by way of example and for purposes ofillustrative discussion of the embodiments of the present invention onlyand are presented in the cause of providing what is believed to be themost useful and readily understood description of the principles andconceptual aspects of the present invention. In this regard, no attemptis made to show structural details of the present invention in moredetail than is necessary for the fundamental understanding of thepresent invention, the description taken with the drawings makingapparent to those skilled in the art how the several forms of thepresent invention may be embodied in practice.

FIG. 1 shows a system used for tissue expansion, which may include atissue expander 100, a magnet 110, and a fluid delivery system 120. Themagnet 110 may be used to detect a particular portion of the tissueexpander 100, such as an access port 140 (also called an implant port).The fluid delivery system 120 may include a needle 130 or other end usedto access the interior of the tissue expander 100. The fluid deliverysystem 120 may provide a fluid to the interior (e.g., internal cavitydefined by an implant shell 115) of the tissue expander 100 to cause thetissue expander 100 to expand. In some embodiments, the fluid deliverysystem 120 may also be used to access the interior of the tissueexpander 100 to remove fluid from the tissue expander 100, which maycause the tissue expander 100 to contract or deflate.

FIG. 2 shows an example of a fluid delivery system 200 providing accessto an access port 210 of a tissue expander 220 comprising an implantshell 215. The fluid delivery system 200 may include a needle 230 and atube 240 to provide fluid to the interior of the tissue expander 220 viathe access port 210 (e.g., inflation/deflation port). The needle maypuncture the access port 210 to provide fluid to, or remove fluid from,the interior (e.g., internal cavity) of the tissue expander. The accessport 210 may be provided with a self-healing/sealing material that,after being punctured by a needle of the fluid delivery system 200,reforms an airtight and liquid tight seal. In some instances, the fluiddelivery system 200 may utilize a tip other than a needle that may becapable of delivering a fluid to, and removing fluid from, the tissueexpander 220.

A pressure differential may be created to cause fluid to flow into orout of the tissue expander 220. For example, a positive pressure may beprovided from outside the tissue expander 220, which positive pressurecauses inflation of the tissue expander 220. In one example, a syringe250 may be used to provide the positive pressure. In another example, anegative pressure may be provided from within the tissue expander 220 todraw fluid out of the tissue expander 220 for deflation of the tissueexpander 220. Alternatively, pumps or valves may be utilized to assistwith fluid flow.

FIG. 3 provides an example of a tissue expander 300 in accordance withan embodiment of the invention. The tissue expander 300 may include aninside cavity 305 (e.g., internal cavity) and one or more channels 310(also referred to herein as a delivery canal) around an implant shell315. The inside cavity 305 may be defined by the implant shell 315. Theimplant shell 315 may be configured to contain a fluid within the insidecavity 305 in a fluid-tight manner, such that the tissue expander 300may be inflated and deflated. The tissue expander 300 may include animplant port 320, which may be similar to access port 210 describedherein. The implant port 320 may provide access to the inside cavity 305of the implant and is where saline, water, air, or any other fluid, maybe injected into or removed from the interior of the implant shell 315for inflation and deflation of the tissue expander 300. Thus, an implantport 320 may provide fluidic access to the interior of the implant shell315.

The implant shell 315 may have any shape and be composed of any suitablematerial in accordance with aspects of the invention. For example, theimplant shell 315 may have a roughly spherical or hemispherical shape.Alternatively, the implant shell 315 may have an elongated shape. Theimplant shell 315 may also form various shapes that are suited forimplanting into various locations of a subject's body. Such shapes maybe designed to conform to a breast, scalp, face, neck, hands, arms,legs, or any other portion of a subject's body.

In embodiments, the one or more channels 310 about the implant shell 315may provide a delivery/drainage system. Any discussion herein of adelivery/drainage system, channels, or canals may also apply to systems,channels, canals, or regions that may be used for delivery of a fluidand/or drainage/retrieval of a fluid. In embodiments, adelivery/drainage system may be connected to the implant shell 315. Insome instances, the delivery/drainage system can be around the implantshell 315 or surround portions of the surface of the implant shell 315.The delivery/drainage system may leave at least a portion of the implantshell 315 exposed. Alternatively, the delivery/drainage system maysubstantially cover the entire exterior surface of the implant shell315. The delivery/drainage system may be in fluidic communication withan exterior of the tissue expander 300 while not being in fluidiccommunication with the interior, e.g., inside cavity 305, of the implantshell 315 (i.e., the delivery system is fluidically isolated from thecavity defined within the implant shell).

As described herein, a pocket 330 is the space around a tissue expander300 implant when the tissue expander 300 is implanted in a subject'sbody. The subject's body may form the pocket 330 as an area withoutblood vessels and, therefore, the pocket 330 may be isolated fromantibiotics that are normally carried by the subject's vascular system.

In accordance with aspects of the invention, however, fluidcommunication with the pocket 330, or space or compartment around thetissue expander 300, may be provided via a percutaneous port such as apocket port 340 and one or more channels 310 as described herein. Inthis manner, implementations of the invention may be used to deliverantibiotics, or any other fluids, to the pocket 330. Such communicationmay be provided for the drainage of any fluid within the pocket 330, orfor the delivery of any fluid to the pocket 330. Devices in accordancewith aspects of the invention may be adaptable to provide either or bothof these functions.

The tissue expander 300 may also include a pocket port 340. Inembodiments, the pocket port 340 may communicate with the channel(s) 310around the implant shell 315. Thus, a pocket port 340 may providefluidic access to a delivery/drainage system, which may include thechannel(s) 310 and be in fluid communication with the pocket 330. Thepocket port 340 can serve to deliver antibiotics or other fluidsdirectly to the pocket 330 or it can be used to aspirate fluid from thepocket 330. In some instances, the pocket port 340 may be integral tothe tissue expander 300, such as being formed integrally with theimplant shell 315.

In some embodiments, at least one of the implant port 320 and pocketport 340 may comprise one or more remote ports. A remote port may beseparate from the implant shell 315 portion of the tissue expander 300.For example, a separate area may be created surgically for a remote portto rest in or on the subject body. The remote port may be connected tothe tissue expander 300 by a tubing system. In some embodiments, atissue expansion system can have one or two remote ports fluidlyconnected to the inside cavity 305 of the shell 315 and/or to thechannel system 310. The remote port can be disengaged (pulled out) whenit is desirable to keep the tissue expander implanted in the patient fora long time and take out the port through a separate small incision.

An implant port 320 may be an integrated in the implant shell 315 of thetissue expander 300, or a remote port may be provided that provides thesame function as the implant port 320. Similarly, a pocket port 340 maybe integrated in the implant shell 315 of the tissue expander 300, or aremote port may be provided that provides the same function as thepocket port 340. Any number of additional ports may be provided whichmay be integral to the tissue expander or which may be provided as aremote port.

The tissue expander may have a channel system 310 (also called a channelor delivery canal) in accordance with embodiments of the invention. Insome embodiments, the channel system 310 may include a french drain typetubing system that can be integral and tightly bound to the implantshell 315 of the tissue expander 300. The channel system 310 can belocated anywhere and in any configuration on the implant shell 315 ofthe tissue expander 300. In some instances, the channel system 310 maybe located anywhere on the tissue expander 300 implant. However, in someinstances, it may be preferable to provide the channel system 310 on theposterior surface of the implant shell 315, with respect to theorientation of the tissue expander 300 within the subject's body,because when a subject lies in a supine position, the fluid may movedependently posterior due to gravity. In other instances, the channelsystem 310 may be provided on an anterior surface and/or along the sidesof the implant shell 315.

In embodiments, the channel system 310 can be used to deliverantibiotics or other chemicals to a pocket 330 which forms around thetissue expander 300 (e.g., around the implant). The channel system 310can also “suck up” fluid which lies around the implant to be sent forculture or just aspirate sterile fluid. The channel system 310 can havea variety of configurations. In some embodiments, the channel system 310may have a relatively more rigid structure to it than the implant shell315 because it may be desirable to prevent collapse of the channelsystem 310 under pressure of injection or aspiration.

In some embodiments, one or more communication channels 350 may beprovided between the channel system 310 and a pocket port 340 (whetherintegral or remote). The communication channel 350 may be fluidicallyconnected to both the channel system 310 and the pocket port 340 toenable fluid to flow to or from the channel system 310 from the pocketport 340.

As described in greater detail herein, one or more stability tabs may beprovided to a tissue expander 300 in embodiments of the invention. Thestability tab can either be sewn down or can be a solid structureextending like a training wheel from the implant shell and which mayserve to prevent the implant from being turned over or accidentallyflipping over during normal use.

A tissue expansion device may also have an outside covering 360 arrangedon an outer surface of the implant shell 315. The outside covering 360of the tissue expander 300 implant may be composed of an integralsubstance that dissolves over time and exposes the outer surface of theimplant shell 315 over time. This may help prevent biofilms frompersisting on the tissue expander 300. Biofilms are a community ofbacteria which are very hard to treat. Bacteria exist on the surface ofthe implant and often establish these communities when the implant isinitially placed, and there may be small colonies of bacterialcontamination. In some embodiments, the outside covering 360 of thetissue expander 300 implant may be a bonded dissolvable material with orwithout antibiotics, silver, or another metal. The outside covering maystill remain soft.

In embodiments, the outside covering 360 comprises a dissolvingmaterial, such as polydioxanone (PDS). The dissolving material of theoutside covering 360 helps prevent the formation of biofilms on theexterior surface of the tissue expander 300. As the outside covering 360dissolves, the material on which the biofilm is formed collapses,thereby helping eliminate the biofilm.

In accordance with aspects of the invention, a tissue expansion systemsuch as tissue expander 300 may be provided within a capsule 370. Asdescribed herein, a capsule 370 is a fibrous shell that the subject'sbody forms around an implant placed in the body. The implant shell 315and capsule 370 are separate entities and there is a potential space,such as pocket 330, between them. The capsule 370 has very limited bloodsupply and usually has a smooth tough surface. The capsule 370 may forma physical barrier from the subject's body, vascular system, and immunesystem, and may serve as the boundary of a pocket 330.

In some embodiments, a tissue expander 300 may be positioned adjacentto, or in the proximity of, a firm area 380 such as, for example, achest wall, skull, or any other bodily support structure or firm areafrom which to expand skin. In some embodiments, a posterior side of thetissue expander 300 may be the side of the tissue expander 300 locatedmore closely to the firm area 380. An anterior side of the tissueexpander 300 may be the side of the tissue expander located opposite theposterior side, and away from the firm area 380. In some instances, atissue expander 300 is not positioned adjacent to a firm area 380. Insuch situations, the anterior side of the tissue expander 300 may be theside that is closer to the skin of the subject, while the posterior sidemay be the side deeper within the subject.

Thus, in accordance with aspects of the invention and as describedherein, a tissue expander 300 may comprise an implant shell 315, aninternal cavity 305 defined by an interior of the implant shell 315, anda channel 310 on an exterior portion of the implant shell 315. An accessport 320 (also called an access port) provides selective fluidcommunication with the cavity 305 such that the implant shell 315 may beinflated (or deflated) by introducing fluid into (or extracting fluidout of) the cavity 305. The tissue expander 300 may further comprise atleast one channel 310 arranged on an exterior portion of the implantshell 315. A pocket port 340 provides selective fluid communication withthe channel 310 via a communication channel 350. In embodiments, thechannel 310 has a plurality of holes (e.g., apertures, bores, slits,etc.) that provide fluid communication between an interior of thechannel 310 and an exterior of the channel 310. In this manner, thepocket port 340, communication channel 350, and channel 310 provide asystem for selectively introducing fluid to (or extracting fluid from)the pocket 330 around the exterior of the implant shell 315 in thepatient's body. In embodiments, the access port 320 does not communicatewith the channel 310, and the pocket port 340 does not communicate withthe cavity 305. As such, in embodiments, the access port 320 and pocketport 340 comprise mutually exclusive ports for: (i) selectivelycontrolling the inflation/deflation of the tissue expander 300 and (ii)injecting/extracting fluid to/from the pocket 330, respectively.

In accordance with an aspect of the invention, a tissue expander mayinclude one or more inside cavities defined by a tissue expander shelland a surrounding channel system. The tissue expander may be incorporatefeatures, components, or characteristics of other implants such as thosedescribed in: U.S. Pat. No. 5,330,843; U.S. Pat. No. 4,800,901; U.S.Patent Publication No. 2007/0233273; U.S. Pat. No. 6,666,893; U.S. Pat.No. 6,206,930; U.S. Pat. No. 7,575,597; and U.S. Pat. No. 8,454,690, thedisclosures of all of which are incorporated by reference herein intheir entirety.

FIG. 4 shows an additional view of a tissue expander that may be used inaspects described herein implanted in a patient. In embodiments, thetissue expander includes an implant shell 415 provided with anintegrated pocket port 400 and an integrated access port 420 (alsocalled an implant port). The access port 420 may be configured to permitthe introduction of fluid into the interior of the shell 415 forinflating the tissue expander. The pocket port 400 may be fluidicallyconnected to a channel system comprising the delivery canal 430 havingmultiple openings. Fluid may be provided via needle 455 through thepocket port 400 to the delivery canal 430 and out to the areasurrounding the tissue expander, e.g., the pocket. In some embodiments,the fluid may be an antibiotic solution.

The tissue expander may be provided under the skin and/or subcutaneoustissue 460 of a subject. A pocket 470 may be provided as the potentialspace between the tissue expander and the capsule, or tissue surroundingthe tissue expander. When fluid 475 is delivered through the deliverycanal 430, it may be delivered to the pocket surrounding the tissueexpander.

One or more stability tabs 450 may be provided on the tissue expander.In some embodiments, the stability tabs 450 may protrude from beneaththe delivery canal 430.

The tissue expander may have an antibiotic and/or antimicrobial coating480. In some embodiments, the tissue expander may have a dissolvablecover such as PDS or Monocryl. The dissolvable cover, which may or maynot be used in combination with an antibiotic or antimicrobial coating,may prevent or delay the establishment of a biofilm. As the dissolvablecover dissolves away, bacteria loses the ability to attach to the tissueexpander, thereby inhibiting the growth of the biofilm.

Colorant

FIGS. 5 and 6 show aspects of a tissue expander with colorant inaccordance with aspects of the invention. During a skin sparingmastectomy and/or tissue expander reconstruction, the medicalprofessional inflates (expands) a tissue expander by injecting salineinto the interior of the shell of the tissue expander. It is common toinadvertently injure (e.g., puncture) the shell of the tissue expanderwith a suture needle while the medical professional (e.g., surgeon) isclosing the muscle, allograft, dermis, or skin around the tissueexpander. When a medical professional accidentally sticks the tissueexpander with a needle, the tissue expander does not pop but ratherslowly drains a small amount of the saline contained inside the tissueexpander shell. Because the saline is clear (e.g., colorless), themedical professional may not notice the leaking fluid since the wound ismoist and bloody, and also because the leaking saline may visually blendin with clear irrigation fluid that is applied to the wound.

To address this problem, implementations described herein provide atechnical solution to this problem by adding a colorant to the salinethat is used to inflate the tissue expander. The colorant causes thesaline to have a color, rather than being clear. In this manner, whenthe tissue expander is accidentally punctured, the leaking fluid isreadily noticeable due to its color, and the medical professional isprompted to take corrective action regarding the puncture. Although thisdescription uses saline as an illustrative example, it is to beunderstood that implementations are not limited to use with saline, andaspects of this embodiment may be practiced with any clear fluid that isused to fill (e.g., inflate) a tissue expander.

In one embodiment, the colorant is added to the saline prior to thesaline being introduced into the tissue expander. For example, a smallamount of methylene blue is added to a bag of saline before the salinefrom the bag is placed into the tissue expander to inflate the tissueexpander. In this manner, the saline is blue as it is being added to theinterior of the tissue expander. In the event that the tissue expanderis accidentally punctured (e.g., stuck by a needle, manufacturingdefect, etc.), the blue saline leaks from the inside of the tissueexpander to outside the tissue expander and is noticeable by the medicalprofessional (e.g., alerts the medical professional to the puncture).

In other implementations, the colorant is placed in the tissue expanderbefore the tissue expander is inflated with fluid. For example, a dry(dehydrated, powdered, etc.) form of the colorant may be placed insidethe interior of a dry tissue expander. When the medical professionalinjects clear fluid (e.g., saline) into the tissue expander to inflatethe TW, the fluid rehydrates the colorant, and causes the fluid tochange color (e.g., blue). If the tissue expander is punctured, the bluefluid inside the tissue expander leaks out around the area of thepuncture and alerts the medical professional to the puncture. Thisembodiment has a benefit that the colorant can be added at the time ofmanufacture of the tissue expander, rather than the medical professionalhaving to add the colorant. Also, by adding the colorant at the time ofmanufacture, the sterility of the tissue expander may be maintained.

In embodiments, the dehydrated colorant may be placed in many suitablelocations inside the tissue expander, as illustrated in FIG. 5. Forexample, a wafer or sticker or tab of the colorant may be placed on anunderside of the tissue expander fill port (such as access port 140,210, 320 or 420), or on an inside surface of the interior wall of thetissue expander (e.g., on an interior surface of implant shell 115, 215,315, or 415). In all cases, the colorant used may be minimal andbiocompatible. For example, the colorant may comprise methylene bluethat is initially in a dry and solid state inside the tissue expanderprior to the saline being added to the interior of the tissue expander,and that dissolves in the saline and turns the saline blue when thesaline is introduced inside the tissue expander. In a preferredembodiment, the dry colorant is in the form of a wafer, sticker, or tab,rather than a loose powder. This is because a tissue expander ispackaged in a sterilized manner with air inside the tissue expander, andthe medical professional removes the air from the interior of the tissueexpander prior to implanting the tissue expander in the patient body. Apowdered colorant may disadvantageously be sucked out of the tissueexpander when removing the air, but a wafer, sticker, or tab will remaininside the tissue expander during the air removal. However, aspects ofthe invention are not limited to a wafer, sticker, or tab; instead anysuitable colorant may be used, including powder, liquid, dehydratedpowder, etc.

In further embodiments, the colorant may be temperature activated. Forexample, the colorant may not be active at room temperature, and may beactivated when warm saline comes into contact with the colorant.

FIG. 5 shows an example of a tissue expander 505 with a colorant inaccordance with aspects of the invention. The tissue expander 505includes a shell 510 and an access port 515, which may the same as orsimilar to one of the shells and access ports described with respect toFIGS. 1-4. The tissue expander 505 may include a colorant on an interiorsurface of the shell 510, as indicated by reference number 520.Additionally or alternatively, the tissue expander 505 may include thecolorant on an interior surface of the access port 515, as indicated byreference number 525. In embodiments, the colorant is a dry and solidsubstance that dissolves in saline and yields a colored solution whenthe saline is introduced to the interior of the shell 510. In aparticular embodiment, the colorant is a wafer, sticker, or tab ofmethylene blue, as described herein. In FIG. 5, the tissue expander 505contains only air inside the shell 510, and does not yet contain anysaline. FIG. 6 shows the tissue expander 505 after saline has beeninjected into the shell 510 via the access port 515. The colorant (shownin FIG. 5) is dissolved in the saline 550 and causes the saline 550 tohave a visible color (e.g., blue).

Any one or more of the colorant aspects described with respect to FIGS.5-6 may be used with any type of tissue expander, including but notlimited to any of the tissue expanders depicted in FIGS. 1-4. Any one ormore of the various colorant aspects described with respect to FIGS. 5-6may be used alone or with the tread described with respect to FIGS. 7-11and/or the locator described with respect to FIGS. 12-14.

Tread

FIGS. 7-11 show aspects of a tissue expander tread in accordance withaspects of the invention. Conventional tissue expanders suffer from theproblem that the implanted tissue expander can turn, spin, or dislodgefrom its initial position within the patient body. Such movement mayresult in an unwanted position of the tissue expander within the body(such as the tissue expander flipping within the body), or potentialdamage to the tissue expander which can require replacing the tissueexpander.

A tissue expander may be sutured to the patient body to prevent movementof the tissue expander within the patient body. For example, as shown inFIG. 4, the tissue expander may include tabs that are configured to besutured to a portion of the patient body (e.g., the chest wall). Suturescan be disadvantageous, however, when later removing an implanted tissueexpander since the medical professional must locate and cut the sutureto release the tissue expander from the patient body.

To address this problem, implementations described herein provide atechnical solution to this problem by providing a tread or grippingpattern that is provided on the exterior of a tissue expander (tissueexpander) to prevent movement and slippage of the tissue expander withinthe patient body when the tissue expander is implanted in the body. Forexample, FIG. 7 shows a tissue expander 700 including a shell 710 and anaccess port 715, which may the same as or similar to one of the shellsand access ports described with respect to FIGS. 1-4. In embodiment, thetissue expander 700 includes treads 705 formed on an outer surface 707of the shell 710 in accordance with aspects of the invention. Inembodiments, the outer surface 707 is a backside (or underside) of theshell that is configured to lay against the chest wall of the patientwhen the tissue expander is implanted in the patient, as depicted inFIG. 4. The treads 705 may be ridges or material similar in pattern tothe tread of a running shoe or hiking boot. The ridges may be dividedinto sections that are spaced in different configurations and/orpatterns. The ridges may have rounded or sharp edges.

A single surface of the tissue expander (e.g., the bottom exteriorsurface) may have different ridges oriented in different directions toprevent movement in many different directions. For example, as shown inFIG. 8, a backside outer surface of the shell 710′ of the tissueexpander 700′ may be divided into four areas 715 a-d, and each area mayhave a plurality of ridges 705′ that extend in a direction that isunique to that area. The differently aligned treads 705′ in thedifferent areas 715 a-d contribute to a multi-vector tissue expanderstability to different directional forces within the patient body.Numbers of areas other than four may be used within the scope of theinvention. The areas need not be of the same size as one another, andneed not be the same shape as one another.

FIG. 8 shows the tread 705′ covering substantial the entire backsideouter surface of the shell. FIG. 9 shows an embodiment of a tissueexpander 700″ in which less than the entire backside outer surface ofthe shell 710″ is provided with tread spots 730 a-e. Each of the treadspots 730 a-e may have plural treads 705″ aligned in a differentdirection than the other spots. The tread spots 730 a-e may be added byadhesive, weld, or may be integrally molded with the exterior surface ofthe tissue expander. Untreaded areas 735 of the backside outer surfaceof the shell 710″ between the tread spots 730 a-e also permit tissue towedge between the tread spots 730 a-e and thus further assist withstabilizing the implanted tissue expander 700″ inside the patient.Different spots may have different shapes (e.g., different diameters).

As shown in FIGS. 10 and 11, the tread 705′″ may have a concave shapethat is configured to fit against a rib bone in the patient in which thetissue expander 700′″ is implanted. For example, the tissue expander700′″ may have three or so such treads 705′″ on a backside outer surfaceof the shell that is configured to rest against the patient chest wallwhen the tissue expander 700′″ is implanted in the patient. As shown inFIG. 11, the treads 705′″ may be specifically placed on the tissueexpander 700′″ (e.g., by adhesive, weld, etc.) to match the spacing “S1”of the patient's ribs R1, R2. Specifically, the spacing “S1” of the ribsR1, R2 may be measured, and the tissue expander 700′″ may be constructedby forming or attaching the treads 705′″ on the backside outer surfaceof the shell such that the spacing “S2” between adjacent treads 705′″matches the measured spacing “S1” of the ribs R1, R2. The treads 705′″may be selected from a plurality of different size treads to closelymatch the size (e.g., diameter) of the particular patient ribs.Alternatively, the diameter of a rib R1 may be measured, and the tread705′″ that is associated with that rib may be formed (e.g., constructed)to match the measured diameter of the rib, e.g., such that the diameterof the concave surface of the tread 705′″ is the same as the measureddiameter of the rib. In this manner, different ones of the treads 705′″on a single tissue expander may have different diameters of theirrespective concave surfaces, based on the measured diameters of theindividual ribs of the patient.

Any one or more of the various tread aspects described with respect toFIGS. 7-11 may be used with any type of tissue expander, including butnot limited to any of the tissue expanders depicted in FIGS. 1-4. Anyone or more of the various tread aspects described with respect to FIGS.7-11 may be used alone or with the colorant described with respect toFIGS. 5 and 6 and/or the locator described with respect to FIGS. 12-14.

Locator

FIGS. 12-14 show aspects of a tissue expander locator in accordance withaspects of the invention. A problem with current tissue expanders isthat, when the tissue expander is implanted and covered by the patientskin, the tissue expander is not visible to the medical professional andis at risk of having its shell punctured by a needle when the medicalprofessional is attempting to insert that needle through the accessport, e.g., for insufflating (e.g., injecting saline into) the implantedtissue expander. Missing the access port with the needle can puncturethe tissue expander and deflate the tissue expander, which requires thepatient to undergo another surgery to replace the damaged tissueexpander Implementations of the invention provide a technical solutionto this problem by providing a computer-based locator that is configuredto locate an access port of a tissue expander that is under the skin ofa patient (i.e., implanted under the skin, not visible to the nakedeye), and display a location of the access port on a visual display of acomputing device, thereby guiding the medical professional to the accessport and minimizing the risk of inadvertently puncturing the tissueexpander. This solution helps the medical professional insert theinsufflation needle into the access port in a direction that isperpendicular to the plane of the access port.

In embodiments, a portable or a hand held computing device is providedwith hardware and software that is structured and arranged to locate aport of a tissue expander that is under the skin of a patient (i.e.,implanted under the skin, not visible to the naked eye), and display alocation of the port on a visual display of the computing device. Thehand held computing device may be a smartphone or the like. In aparticular smartphone embodiment depicted in FIG. 12, an electromagneticdetecting device 1205 is attached to the smartphone 1210, e.g., via theinput/output port 1215 of the smartphone 1210. Software running on thesmartphone 1210 interprets signals from the electromagnetic detectingdevice 1205 and produces a visual display 1220 of the detected port onthe display 1225 of the smart phone 1210. The electromagnetic detectingdevice 1205 is configured to detect the metallic access (fill) port ofthe tissue expander and produce signals that are used to create thedisplay 1220 based on such detection.

As shown in FIGS. 13 and 14, the detection and resulting visual displayare sensitive to roll, pitch, and yaw about three orthogonal axes. Inthis manner, the roll/pitch/yaw orientation of the smartphone 1210 withthe installed electromagnetic detecting device 1205 can be changed bythe user (e.g., medical professional) by moving the smartphone 1210, andthe visual display of the port will change accordingly.

For example, FIGS. 13 and 14 depict a tissue expander 1240 including anaccess port 1250 implanted in a patient (e.g., under skin 1260). Thetissue expander 1240 and access port 1250 may be the same as or similarto a tissue expander and access port already described herein withrespect to FIGS. 1-4. A smartphone 1210 having the detecting device 1205is on an opposite side of the skin 1260 from the tissue expander 1240.As shown in FIG. 13, when the smartphone 1210 and the attached detectingdevice 1205 are positioned such that a first plane 1270 of the detectingdevice is not substantially parallel to a second plane 1275 of the port1250, the display 1225 of the smart phone 1210 displays a first shape1280 that indicates incorrect alignment. As shown in FIG. 14, when thesmartphone 1210 and the attached detecting device 1205 are moved into aposition such that a first plane 1270 of the detecting device 1205 issubstantially parallel to a second plane 1275 of the port 1250, thedisplay 1225 of the smartphone 1210 displays a second shape 1285 thatindicates correct alignment. As used herein, substantially parallelmeans exactly parallel with a tolerance of plus or minus a few degrees(e.g., 5 degrees) of rotation in any one or more of the roll, pitch, andyaw directions.

The software may be configured to provide an audible and/or visualindication of when the electromagnetic detecting device 1205 is in apredefined “correct” location and orientation relative to the port 1250.For example, the indication may be a change in color (red for wrong,green for correct), a change in size and or shape (bigger circle when inthe correct location and orientation), or cross hairs may appear when inthe correct location and orientation, etc. In particular embodiments,the first shape 1280 is a different shape than the second shape 1285.For example, the first shape 1280 may be elliptical based on thedetected angular difference between the first plane 1270 and the secondplane 1275, and the second shape 1285 may be circular. In particularembodiments, the first shape 1280 is a different color than the secondshape 1285. For example, the first shape 1280 may be red and the secondshape 1285 may be green to provide a visual indication of the correctalignment of the detecting device 1205 relative to the unseen port 1250.In further embodiments, the smartphone 1210 or the detecting device 1205are provided with a light that is activated to project a pattern on thepatient skin when the correct alignment is achieved. In this manner,implementations of the invention may be used to (1) locate the tissueexpander port under the skin, and (2) determine a spatial orientation ofthe injection plane of the tissue expander port, so that the medicalprofessional can insert a needle through the skin and into the tissueexpander port at an angle that is perpendicular to the injection planeof the tissue expander port.

Any one or more of the various locator aspects described with respect toFIGS. 12-14 may be used with any type of tissue expander, including butnot limited to any of the tissue expanders depicted in FIGS. 1-4. Anyone or more of the various locator aspects described with respect toFIGS. 12-14 may be used alone or with the colorant described withrespect to FIGS. 5 and 6 and/or the tread described with respect toFIGS. 7-11.

Additional aspects of the invention include manufacturing a tissueexpander with one or more of the improvements described herein. Evenfurther aspects of the invention include providing instructions forusing a tissue expander having one or more of the improvements describedherein, e.g., instructions for how to implant and/or insufflate thetissue expander as described herein. The instructions may be at leastone of printed and video.

It is noted that the foregoing examples have been provided merely forthe purpose of explanation and are in no way to be construed as limitingof the present invention. While the present invention has been describedwith reference to an exemplary embodiment, it is understood that thewords which have been used herein are words of description andillustration, rather than words of limitation. Changes may be made,within the purview of the appended claims, as presently stated and asamended, without departing from the scope and spirit of the presentinvention in its aspects. Although the present invention has beendescribed herein with reference to particular means, materials andembodiments, the present invention is not intended to be limited to theparticulars disclosed herein; rather, the present invention extends toall functionally equivalent structures, methods and uses, such as arewithin the scope of the appended claims.

What is claimed:
 1. A tissue expander device, comprising: a selectivelyinflatable and deflatable shell that is configured to be implanted; atleast one port for selectively inflating and deflating the shell; acolorant inside the shell before the shell is inflated with fluid,wherein the colorant mixes with the fluid upon injection of fluid intothe shell.
 2. The tissue expander device of claim 1, wherein thecolorant is dehydrated and the injecting the fluid into the shell toinflate the body rehydrates the colorant.
 3. The tissue expander deviceof claim 1, wherein, upon mixing with the injection fluid, the colorantturns the clear injection fluid to another non-clear color.
 4. Thetissue expander device of claim 1, wherein a wafer or sticker or tab ofthe colorant is placed on an underside of the at least one port, or onan inside surface of the interior wall of the shell.
 5. The tissueexpander device of claim 4, wherein the colorant is biocompatible.
 6. Atissue expander device, comprising: a selectively inflatable anddeflatable shell that is configured to be implanted; at least one portfor selectively inflating and deflating the shell; a tread on anexterior surface of the shell.
 7. The tissue expander device of claim 6,wherein the tread is on a back side of the shell.
 8. The tissue expanderdevice of claim 6, wherein the tread comprises a first area and a secondarea, the first area has a plurality of treads in a first direction, andthe second area has a plurality of treads in a second directiondifferent than the first direction.
 9. The tissue expander device ofclaim 8, wherein the tread comprises a third area and a fourth area, thethird area has a plurality of treads in a third direction, the fourtharea has a plurality of treads in a fourth direction, and the first,second, third, and fourth directions are all different from one another.10. The tissue expander device of claim 6, wherein the tread is one ofadhesively attached to the shell, welded to the shell, and molded withthe shell.
 11. The tissue expander device of claim 6, wherein the treadcovers the entire back surface of the shell.
 12. The tissue expanderdevice of claim 6, wherein the tread covers discrete spots on the backsurface of the shell.
 13. The tissue expander device of claim 6, furthercomprising a colorant inside the shell before the shell is inflated withfluid, wherein the colorant mixes with the fluid upon injection of fluidinto the shell.
 14. A system, comprising: a computing device with avisual display screen; a detector connected to the computing device thatis configured to detect a port of a tissue expander that is implantedunder skin of a patient; software running on the computing device thatreceives signals from the detector and causes the visual display screento show a visual representation of a location of the detected port ofthe tissue expander.
 15. The system of claim 14, wherein the detectorand software are configured to change the display based on changing atleast one of the location and orientation of the detector relative tothe port.
 16. The system of claim 14, wherein the detector and softwareare configured to change the display based on at least one oftranslating, rolling, pitching, and yawing the detector relative to theport.
 17. The system of claim 14, wherein the detector and software areconfigured to change the display to show visual indicator when thedetector is located and oriented in a correct position relative to theport.
 18. The system of claim 14, wherein the computing device is asmartphone.
 19. The system of claim 18, wherein the software is an apprunning on the smartphone.